Protocol summary

Summary
Ulcerative colitis (UC) is a chronic mucosal inflammation which can affect any parts of colon but rectum is involved in the most of the cases. This disease characterized by bloody diarrhea, colicky abdominal pain, urgency and tenesmus.The main pathogenesis of this disease is already unknown. Many studies are focused on the role of abnormal mucosal immune responses to enteric bacteria triggered by environmental Factors. We conducted a randomised clinical trialPatients who took NSAIDs, vasodilators, corticosteroids (some studies showed they might affect tissue oxygenation) and patients with past medical history of ischemic heart disease, pulmonary disorders (COPD, asthma), severe anemia and vascular disease ( vasculitis) and Diabetes which can cause tissue hypoxia were excluded. study to assess the role of ischemia in UC. 20 patients with UC, 20 people without any history of bowel disease and ten paraffin wax embedded tissue species from mesenteric ischemia and ten paraffin wax embedded tissue species include infectious colitis entered the study. Patient group underwent colonoscopy and endoscopy. Three samples were taken from the colon; one from ulcerative tissue, one from normal intestinal tissue and the last one from body of the stomach. Endoscopy and colonoscopy were also done for control group (they had referred for screening) with preparing one sample from colon and another from body of stomach. Systemic arterial blood gas sampling (ABG) was performed from radial artery after Allen testing. More over, perirectal capillary blood gas analysis using endoscopic ultrasound (EUS) with 100 cc normal saline and 80 mg gentamycine enema immediately before the procedure was performed. Thirty minutes after perirectal capillary blood gas was taken, blood culture was done to rule out bacteremia. Pathological species transferred to department of pathology for measuring HIF1a. Blood gas samples were assessed within 5 minutes in laboratory by pathologist, and results were recorded.Statistical analysis was done by the SPSS Statistics Data Document. (V 19.2) Differences among groups were determined using the general repeated ANOVA.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201208139736N1
Registration date: 2012-08-21, 1391/05/31
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-08-21, 1391/05/31
Registrant information
Name
Seyed Amir Mirbagheri
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6643 7147
Email address
samirbagheri@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
The study was financially supported by university research center, Tehran University of Medical Sciences
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2012-10-22, 1391/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of ischemia and tissue hypoxia in the pathogenesis of ulcerative colitis: a case control study
Public title
Effects of ischemia and tissue hypoxia in the pathogenesis of ulcerative colitis: a case control study
Purpose
Diagnostic
Inclusion/Exclusion criteria
We conducted a randomised clinical trial study to assess the role of ischemia in UC. 20 patients with UC, 20 people without any history of bowel disease and ten paraffin wax embedded tissue species from mesenteric ischemia and ten paraffin wax embedded tissue species include infectious colitis entered the study. UC is diagnosed by clinical symptoms, sigmoidoscopy or colonoscopy findings and pathological species on biopsy.1Patients who took NSAIDs, vasodilators, corticosteroids (some studies showed they might affect tissue oxygenation) and patients with past medical history of ischemic heart disease, pulmonary disorders (COPD, asthma), severe anemia and vascular disease ( vasculitis) and Diabetes which can cause tissue hypoxia were excluded. Control group included 10 people who were referred for screening with all the features mentioned above except history of clinical or colonoscopic bowel disease. Both group had the same age, sex and lived in the same height above the sea level.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical science
Street address
Tehran,Keshavarz Boulevard,pursina Aveniue
City
Tehran
Postal code
Approval date
2012-03-07, 1390/12/17
Ethics committee reference number
90-04-30-14993-52174

Health conditions studied

1

Description of health condition studied
Ulcerative Colitis
ICD-10 code
K51
ICD-10 code description
Ulcerative colitis

Primary outcomes

1

Description
Pericapillary Blood Gas
Timepoint
Before intervention and after intervention
Method of measurement
Laboratory data reports

2

Description
SystemicArterial Blood Gas
Timepoint
Before intervention and after intervention
Method of measurement
Laboratory data repots

3

Description
Tissue ischemic factors
Timepoint
Just after sampling
Method of measurement
Specila kits

Secondary outcomes

empty

Intervention groups

1

Description
Control group 1 included 20 people who are referred for screening with all the features of patients group except history of clinical or colonoscopic bowel disease.Endoscopy and colonoscopy will also apply for control group (they had referred for screening) with preparing one sample from colon and another from body of stomach. Systemic arterial blood gas sampling (ABG) is performed from radial artery after Allen testing. More over, Perirectal capillary blood gas analysis using endoscopic ultrasound (EUS) with 100 cc normal saline and 80 mg gentamycine enema immediately before the procedure is performed. Thirty minutes after perirectal capillary blood gas was taken, blood culture was done to rule out bacteremia .Lipid profile,CBC,FBS,EKGG and S/C was done for all of them.Pathological species transferred to department of pathology for measuring HIF1a. Blood gas samples were assessed within 5 minutes in laboratory by pathologist, and results were recorded.
Category
Diagnosis

2

Description
Control group 2:Ten paraffin wax embedded tissue species from mesenteric ischemia and ten paraffin wax embedded tissue species include infectious colitis entered the study.For this group just tissue ischemic factor by special kits will be assessed.
Category
Diagnosis

3

Description
Patients group interventions: Ten patients with Ulceratve Colitis are selected.Patients should be known case of UC and are diagnosed by clinical symptoms, sigmoidoscopy or colonoscopy findings and pathological species on biopsy.patients group will go under colonoscopy and endoscopy. Three samples are taken from the colon; one from ulcerative tissue, one from normal intestinal tissue and the last one from body of the stomach Systemic arterial blood gas sampling (ABG) are performed from radial artery after Allen testing. More over, Perirectal capillary blood gas analysis using endoscopic ultrasound (EUS) with 100 cc normal saline and 80 mg gentamycine enema immediately before the procedure was performed. Thirty minutes after perirectal capillary blood gas was taken, blood culture is done to rule out bacteremia .Pathological species transfer to department of pathology for measuring HIF1a. Lipid profile, CBC,FBS, S/C, EKG will be done for the patients.Blood gas samples شقثassessed within 5 minutes in laboratory by pathologist, and results were recorded
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Amira'lam hospital
Full name of responsible person
Dr Seyed Amir Mirbagheri
Street address
Tehran, Saadi Aveniue
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Faculty of Medicine, Tehran University of Medical science, Tehran, Iran
Full name of responsible person
Golband
Street address
Tehran, Keshavarz Boulvard, Poursina Aveniue
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Faculty of Medicine, Tehran University of Medical science, Tehran, Iran
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Faculty of Medicine, Tehran University of Medical science
Full name of responsible person
Dr Masih Ttajdini
Position
Medical Student
Other areas of specialty/work
Street address
Faculty of Medicine, Tehran University of Medical science
City
Tehran
Postal code
Phone
+98 21 6643 7147
Fax
Email
Drmasih84@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Medicine, Tehran University of Medical science
Full name of responsible person
Dr Seyed Amir Mirbagheri
Position
Internal medicine specialist, Digestive system disorders sub specialist
Other areas of specialty/work
Street address
Faculty of Medicine, Tehran University of Medical science
City
Tehran
Postal code
Phone
+98 912 146 2041
Fax
Email
Drmasih84@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Medicine, Tehran University of Medical science
Full name of responsible person
Dr Masih Tajdini
Position
Medical Student
Other areas of specialty/work
Street address
Faculty of Medicine, Tehran University of Medical science
City
Ttehran
Postal code
Phone
Fax
Email
Drmasih84@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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